What Not To Do: FDA Reviewer Talks Cancer Drug Development Mistakes
Using anonymous examples at the recent AACR meeting, FDA’s Tatiana Prowell highlights mistakes made and lessons learned in oncology drug reviews.
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COPD Patient-Reported Outcome Questionnaire Is Early Example of FDA Drug Development Tool “Approval” Process
FDA finalizes the "qualification process for drug development tools." The topic won't get as much attention as Breakthrough Therapy or Accelerated Approval, but the head of the drug center thinks this is a very big deal. A COPD outcomes assessment is an early example of the process in action.
American Society of Clinical Oncology draft recommendations provide benchmarks for Phase III oncology drug trials, including a minimum 20% improvement in overall survival, with a higher bar for certain diseases.
J&J’s abiraterone gains FDA clearance for the new claim without statistical significance for its 5-month survival advantage, but Medivation’s Xtandi is waiting in the wings – and its pre-chemo trial, PREVAIL, is likely to show a significant effect.